Medical Pot Activists Fear New Epilepsy Drug Will Undercut Them

Marijuana (cannabis) is already used as a potential treatment for a number of neurologic conditions, including epilepsy. There are legal issues surrounding access to cannabis, as well as a lack of scientific research on the usefulness and safety of marijuana as a treatment for seizures. Additionally, many different substances containing cannabis are being used which makes it difficult to study. (1)

A new drug made of marijuana is already used to treat a rare form of epilepsy. Now the manufacturer of the drug is going to seek approval from the U.S. Food and Drug Administration. But medical marijuana activists are fearful FDA approval will hurt them politically. (2)

The drug is called Epidiolex and it is almost a pure extract of cannabidiol, or CBD. It contains very little tetrahydrocannabinol, or THC, that gives marijuana users a high. CBD products are the current rage in medicinal pot products, and activists fear that if the maker of Epidiolex manages to get FDA approval, it could undercut the political momentum of the medical marijuana movement.

Anup Patel, a pediatric neurologist who oversees Epidiolex’s clinical trials at Nationwide Children’s Hospital in Columbus, insists the drug contains the optimal known marijuana compound for treating seizures. He cited a study that found children can be hurt by using the whole plant. (3)

Patel laments that children with epilepsy are being used — including during an unsuccessful Ohio ballot campaign last year — to push for medical marijuana legalization.

“People are mixing terms, mixing ideas,” he said. “I’m not sure if that’s just because of confusion, lack of knowledge or on purpose.”

Karmen Hanson, the expert on marijuana policy for the nonpartisan National Conference of State Legislatures, said the two sides are at odds.

“The argument for traditional (whole-plant) medical marijuana is that people know what works for them — whether they’re going to make their own concentrates or vape or combust, use flowered products, oils, you name it — so they want to protect their ability to do that,” she said. “The other camp wants to see the head-to-head science, to give it more scientific validity, to elevate the products that are produced in terms of reliability and consistency.”

The FDA has not yet found any botanical form of marijuana to be safe or effective to treat any disease or condition, spokesman Michael Felberbaum said. If approved, Epidiolex would be the first. Two synthetic cannabinoids — Marinol and Cesamet — are available. (4)

FDA approval would allow any doctor to prescribe Epidiolex to any patient, and it would be covered by insurance. No law or ballot issue would be required.

Many medical marijuana activists fear Epidiolex approval will mark the beginning of Big Pharma’s takeover of the marijuana plant, undercutting patients’ ability to treat themselves as they see fit.

“We are not concerned with the pill (actually oil) form of a natural plant,” said Wendy Johnson, who represents the Cannabis Safety Association in Ohio, where medical marijuana legislation was introduced last week. “In fact, it is looked upon very unfavorably and as a stumbling block on our way to whole plant.”

In the video below, dr. Orrin Devinsky from the NYU Epilepsy Center talks about the medicinal use of marijuana or cannabis in treating epilepsy and seizures.

When a person has epilepsy and conventional treatments do not work, as is the case for roughly 30% of people with epilepsy, it is not unreasonable to consider cannabis. This is why some states have approved it for “compassionate access.” However, this should only be considered after a thorough evaluation at a specialized epilepsy center and once conventional treatments (pharmacologic and nonpharmacologic) have been reasonably tried.